UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053962 |
|---|---|
| Receipt number | R000061592 |
| Scientific Title | Effects of consumption of the test food on psychological stress in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison study |
| Date of disclosure of the study information | 2024/03/25 |
| Last modified on | 2024/09/30 16:54:05 |
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Basic information
Public title
Effects of consumption of the test food on psychological stress in healthy Japanese
Acronym
Effects of consumption of the test food on psychological stress in healthy Japanese
Scientific Title
Effects of consumption of the test food on psychological stress in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison study
Scientific Title:Acronym
Effects of consumption of the test food on psychological stress in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on psychological stress in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The Profile of Mood States 2nd Edition (POMS2)
Key secondary outcomes
1. Saliva test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
<Duration>
Three days
<Test food>
Period I: Active food
Period II: Placebo food
*The intervention sequence is Period I to Period II.
*Washout period is for one week or more
Interventions/Control_2
<Duration>
Three days
<Test food>
Period I: Placebo food
Period II: Active food
*The intervention sequence is Period I to Period II.
*Washout period is for one week or more
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1. Japanese
2. Men
3. Individuals aged 40 or more and less than 60
4. Healthy individuals
5. Individuals who do not regularly do calculation work (such as using calculator, playing Sudoku, or what the participants consider to be calculation work)
6. Individuals who are judged as eligible to participate in the study based on the results of the Beck Depression Inventory-II at screening (before consumption; Scr) by the physician
7. Individuals whose score of Tension-Anxiety (TA) in the POMS2 is high among those who agreed to participate in the study
Key exclusion criteria
Individuals who
1. are under medical treatment or have a medical history of malignant tumor, heart failure, and/or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are under treatment for any of cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes, dyslipidemia, hypertension, or other chronic diseases
4. are under medical treatment for chronic fatigue syndrome or menopausal syndrome
5. take "Foods for Specified Health Uses" or "Foods with Functional Claims"
6. take/use medications, herbal medicines, and supplements
7. are allergic to medications and/or the test food related products (particularly fish, type I collagen, and gelatin)
8. have been enrolled in other clinical studies within the last 28 days before agreeing to participate or plan to participate another study during the study
9. are good at or like calculation work (such as using calculator, playing Sudoku, or what the participants consider to be calculation work)
10. have a final education in the sciences
11. take collagen/gelatin-rich foods at least 2 days (2 servings) a week
12. work in physical labor (such as transporting heavy objects)
13. live with requiring long-term care persons
14. live with infants (age <1)
15. sleep in the same room with children aged 1~5
16. sleep with more than one person (except when two mattresses are combined)
17. have irregular sleeping time or habit (sleeping more than two hours different from usual bedtime by at least two days a week) due to work such as a late-night shift
18. have nocturia three times or more from 22:00 to 3:00 the next day
19. drink to excess (average of more than about 20 g/day as absolute alcohol intake) every day
20. take foods or use daily use items with a relaxing effect
21. are judged as ineligible to participate by the physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
ORTHOMEDICO Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
National University Corporation UTSUNOMIYA UNIVERSITY
Name of secondary funder(s)
Nippi, Incorporated
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061592
